Hoosier company receive federal approval for N95 mask production

Hoosier Indiana Face Masks obtains NIOSH approval for N95 respirators

One of the most hopeful news to come out this week is the startup created by a filter manufacturing company based in Rensselaer, which was created in response to the COVID-19 pandemic. They received a federal designation and approval for the manufacturing and distribution of N95 masks.

Indiana Face Mask obtained approval by the National Institute for Occupational Safety and Health, commonly known as a NIOSH approval, which is a federal agency created as a part of the Centers for Disease Control and Prevention (CDC). This institution regulates respirators inside the United States, and we’ll discuss them a little later.  This approval means this company meets the government standards for these work devices.

The company’s vice president was interviewed by Inside Indiana Business, in which they explain their intentions behind this new production line. He told them that they received 20 to 50 calls every day from people trying to get material from them since the COVID-19 pandemic began. So, they thought “this is kind of silly. We already have the hardest part done. We already have the correct materials,” as Clayton Geyer explained.

They announced this initiative in May, and have acquired a 25,000 sq. ft. building in Rensselaer, converting it into a facility for personal protective equipment (PPE) production which is also federally approved. According to Geyer, they’re one of the five companies to obtain the NIOSH designation out of over a thousand that applied for this licensing.

They currently employ 20 people for the production of these masks, and they only expected to hire 14 when they announced the startup in May. However, this number seems to be increasing to 30 people they hope to hire by the end of 2020. According to Geyer, they work five days a week around the clock, but they probably will have to work seven days a week due to the increased PPE demand.

The company expects to produce an approximate 7 million N95 respirators per year, working at full capacity. The vice president of the company explained in his interview that these masks will stay in Indiana initially, intended to be distributed to hospitals, first responders, and other healthcare providers exposed to COVID-19 patients. They’ll also supply, through the Indiana Small Business PPE Marketplace, small businesses and nonprofits.

Understanding N95 masks and why they’re scarce, as well as the meaning of a NIOSH approval

N95 masks are currently the most sought out item due to the COVID-19 pandemic, being a crucial part of the PPE needed in healthcare settings. This is because they’re the best disposable face masks among the ones available at the moment, including surgical or medical masks, and even KN95 masks, which are supposed to be equivalent to N95 masks.

Respirators are important devices used in work settings with respiratory hazards, which are particles that can severely affect the health of the person that inhales them. These are masks that filter out these particles, preventing them from reaching the airways when the wearer inhales. They have many uses in different industries.

NIOSH is an institution we mentioned earlier, and they were created to create science-based recommendations for workplaces in the USA so that their workers stay safe in them. As part of their job, they also regulate respirators based on a set of filtration standards, naming them according to a two-part naming system.

The NIOSH classification takes into consideration the filtration rate of the respirator, indicated with the numbers 95, 99, or 100, as well as the resistance to oil it has, indicated with the letters N, R, or P. These two characteristics tell us the number of airborne particles (those with a minimum size of 0.3 micrometers) from the air the respirator can filter out, and their ability to filter out particles that contain oil, respectively.

N95 masks are those without oil resistance and a percentage of minimum particulate filtration efficacy of 95%, meaning they can filter out at least 95% of the non-oil-based airborne particles the wearer inhales. They can protect against particles like pollen, dust, and smoke, which are potent allergens for many people, but they can also filter out certain bioaerosols, like the flu virus or the new coronavirus, preventing the wearer from getting infected.

When an N95 mask, or any other type of respirator inside the classification, is approved by NIOSH, it means the agency has tested it and it meets all the requirements established by them. This certifies the mask does filter out the amount of particles it says it does, along with other requirements. When these masks are intended for healthcare settings, they also need to be approved by the Food and Drug Administration (FDA).

Since the pandemic began, experts claimed healthcare workers needed these masks to be fully protected, as their antiviral properties could offer protection even in the environments of high risk of exposure to the virus they find themselves in at work. But, an item that was once found for sale anywhere online, it’s now very difficult to obtain by medical centers that need to buy them in bulk or wholesale. Even with enormous efforts made by major companies, including Honeywell and 3M with their 3M N95 masks like the 3M 8210 and the 3M 8511, the production hasn’t been able to meet the gigantic demand.

This is why the CDC recommends the general public, including kids over the age of 2, to make use of the reusable cloth masks that are widely available everywhere. Medical-grade masks and other scarce items, like gloves, gowns, and face shields, must be reserved for first responders and healthcare providers.

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